Company · FR
Biomérieux SA
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 28, 2026 | K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) Biomérieux, Inc. | LON |
| Apr 21, 2026 | K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) bioMérieux SA, FR | JWY |
| Jun 12, 2025 | K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) Biomérieux, FR | JWY |
| Oct 5, 2023 | K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD Biomérieux, FR | JWY |
| Jul 8, 2022 | K210793 | VIDAS NEPHROCHECK Biomérieux SA, FR | PIG |
| Feb 4, 2022 | K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) Biomérieux, Inc. | LON |
| May 7, 2020 | K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) Biomérieux SA, FR | JWY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||